Project Manager

Role & responsibilities

Project Management: -

• Lead end-to-end project lifecycle: initiation, planning, execution, monitoring, and closure.
• Develop integrated project plans across workstreams (drug substance, drug product, analytical, regulatory, quality).
• Coordinate cross-functional teams including internal departments, vendors, and external stakeholders.
• Conduct scenario planning, risk assessments, and mitigation strategies.
• Manage project meetings, documentation, and stakeholder communications.

Manufacturing & CMC Oversight

• Oversee Chemistry, Manufacturing, and Controls (CMC) activities across vaccine development phases.
• Support tech transfer, scale-up, validation, and lifecycle management.
• Ensure GMP compliance and readiness for audits and regulatory submissions.

Strategic & Financial Management

• Align projects with organizational strategic goals and KPIs.
• Manage budgets, forecasts, and financial reporting.
• Track expenditures and ensure cost-effective delivery.

Regulatory & Quality Integration

• Coordinate preparation of CMC sections for regulatory filings (IND, IMPD, BLA).
• Interface with regulatory bodies and respond to Health Authority queries.
• Implement CAPA and quality assurance measures.

Workforce & Ecosystem Development (Optional for R&D-focused roles)

• Support training programs, internships, and workforce development initiatives.
• Organize vaccinology courses, webinars, and collaborative events.

Preferred candidate profile

Qualifications:

• Bachelors degree in a scientific field (e.g., Biology, Pharmacy, Chemistry); Master’s or PMP certification preferred.
• 7–12 years of experience in vaccine/biologics project management, manufacturing, or R&D.
• Experience with CDMOs, CROs, and global health organizations.
• Proficiency in project management tools (MS Project, Smartsheet, SharePoint).
• Strong leadership, communication, and stakeholder management skills.

Desirable Skills:

• Knowledge of Six Sigma/DMAIC methodologies.
• Knowledge of SAP/HANA
• Experience in strategic planning and governance.
• Ability to manage international collaborations and multicultural teams.